FDA requiring additional information for Intranasal Naloxone prior to approval.
The FDA recently issued a complete response letter (CRL) to Amphastar Pharmaceuticals in response to a new drug application for Naloxone Hydrochloride 2-mg/0.5 mL Nasal Spray (Intranasal Naloxone).
Amphastar was seeking regulatory approval for the intranasal drug for use in emergency treatment of an opioid overdose, which is characterized by respiratory and central nervous system depression.
The FDA identified problems with user human factors study, device evaluation, and additional concerns. These issues must be addressed and reconciled prior to receiving FDA approval, according to a press release.
Opioid overdose-related deaths have quadrupled since 1999, with more than 500,000 individuals dying from overdoses between 2000 and 2015. Although states have implemented new laws that restrict opioid prescribing and increase access to treatment, individuals are still experiencing the detrimental effects of opioid use disorder.
According to the press release, Amphastar will continue offering naloxone administered through pre-filled syringes. The Naloxone HCI Injection (USP, 2mg/2mL) is approved to reverse narcotic depression resulting from an opioid overdose.
Despite the CRL, Amphastar plans to work to address the issues outlined by the FDA.
"While we are disappointed to have not received approval at this time, we intend to continue to work with the FDA to address their concerns in the CRL and hope to bring Intranasal Naloxone to the market as soon as possible,” said Jack Zhang, PhD, CEO of Amphastar.
Other intranasal overdose treatments have already received regulatory approval, including Narcan Nasal Spray. Originally, the nasal spray was approved as a 4-mg dose, but the FDA recently expanded its indication to include the 2-mg dose.
If Amphastar fixes the issues disclosed by the FDA, another intranasal spray may provide patients with additional treatment options. Additionally, a new approval could even drive prices down through increased competition, and increase patient access to the life-saving treatment.